Alkermes Inc. has announced the completion of patient enrolment in a phase 1/2 clinical study of ALKS 29, the company's undisclosed oral compound for the treatment of alcohol dependence. The multi-centre, randomised, double-blind, placebo-controlled trial is designed to assess the safety and efficacy of ALKS 29 in approximately 150 subjects with alcohol dependence. Alkermes expects to provide top-line results from this study in the first half of calendar 2007.
"Addiction is an underserved disease area where a variety of treatments are needed that can improve outcomes for patients," stated Elliot Ehrich, chief medical officer of Alkermes. "ALKS 29 represents an important opportunity to bring forward a new medication for patients struggling with alcohol dependence, and the completion of enrolment in this clinical trial represents an important step forward in establishing our addiction portfolio."
Alcohol dependence is a serious and chronic disease that affects multiple regions of the brain, providing rationale for the use of medication with psychosocial support as part of an integrated treatment plan. Underlying neurological and genetic factors, as well as environmental factors, play a role in alcohol dependence; therefore, there is a need for a variety of treatment options that can be tailored to best suit patients' needs.
Psychosocial support, such as counselling or group therapy, is the traditional approach for treating alcohol dependence; however, experts in the field increasingly recommend and support a treatment approach that includes a combination of medication and psychosocial support.
Of the more than 18 million Americans who abuse or are dependent on alcohol, approximately 2.2 million seek treatment for their alcohol problems. More than 75 per cent of these patients relapse back to drinking within the first year of beginning treatment using currently available treatment approaches. Alcohol abuse and dependency are an economic burden to society that cost approximately $185 billion annually in the US.
Alkermes Inc is a biotechnology company that develops innovative medicines designed to yield better therapeutic outcomes and improve the lives of patients with serious disease. Alkermes currently has two commercial products Risperdal and Consta, the first and only long-acting atypical antipsychotic medication approved for use in schizophrenia, and marketed worldwide by Janssen-Cilag (Janssen), a wholly owned division of Johnson & Johnson.